Clinical trial · Interventional
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
NCT05907954CI-TRIAL-00105643active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Darovasertib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- darovasertib
- description
- IDE196 (darovasertib) oral open label
- interventionNames
- Drug: Darovasertib
Primary outcomes (4)
- measure
- Incidence of Adverse Events (AEs) and significant laboratory abnormalities
- timeFrame
- from first dose to 28 days after last dose of therapy, approximately 18 months
- description
- Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.
- measure
- Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy * Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is \< 4 mm in thickness requiring treatment * Able to dose orally * ECOG Performance status of 0-1 * No other significant underlying ocular disease * Adequate organ function * Not pregnant/nursing or planning to become pregnant. Willing to use birth control Exclusion Criteria: * Previous treatment with a Protein Kinase C (PKC) inhibitor * Concurrent malignant disease * Active HIV infection or Hep B/C * Malabsorption disorder * Unable to discontinue prohibited medication * Impaired cardiac function or clinically significant cardiac disease * Any other condition which may interfere with study interpretation or results
References
Publications (0)
Data not yet available
No reference posted for this study.